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Jun 30, 2026Regulatory decision

FDA approves labeling supplement for Sun Pharma's LEQSELVI (deuruxolitinib)

The FDA cleared a labeling update for LEQSELVI, Sun Pharmaceutical Industries' oral tablet.

Sun Pharmaceutical Industries received an FDA approval this week for a labeling supplement tied to its drug LEQSELVI.

  • The FDA approved a labeling supplement (SUPPL 2) for LEQSELVI, an oral tablet containing deuruxolitinib phosphate at a strength equivalent to 8mg base, sponsored by Sun Pharmaceutical Industries under NDA217900.1 The submission carried standard review priority, and the agency issued both an approval letter and an updated label as part of the action.

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.